Breast Cancer Stage IVEPCNCT00393341
Quantitation of Endothelial Progenitor Cells as Markers of Tumor Angiogenesis in Breast Cancer
An observational study of Breast Cancer Stage IV and Breast Cancer Stage I, run by Indiana University at 1 site in United States.
Trial summary
We propose to quantitate endothelial progenitor cells (EPCs) in early and advanced breast cancer patients. Peripheral blood will be drawn from the eligible patients. Different type of EPCs will be isolated from the blood and quantitated. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Stage IV, Breast Cancer Stage I, Breast Cancer Stage II
- What is being tested?
- Blood Draw
- Type of treatment
- Surgery or procedure
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Aug 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women 18 or older with breast cancer recieving treatment at IUSCC and willing to donate a blood sample and complete consent form.
Who may be able to join
- Diagnosis of metastatic breast cancer(stage IV), or women with a history of Stage I or II breast cancer disease who are currently disease free Women greater than or equal to 18 years of age Ability to understand and the willingness to sign an informed consent
Who cannot join
- Chemotherapy, radiation, or surgery within the past 4 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
We propose to quantitate endothelial progenitor cells (EPCs) in early and advanced breast cancer patients. Peripheral blood will be drawn from the eligible patients. Different type of EPCs will be isolated from the blood and quantitated.
Read the detailed description
Accumulating evidence emphasizes the emerging role of circulating endothelial cells (CECs) and endothelial progenitor cells (EPCs) in tumor angiogenesis as surrogate markers and in the efficacy of anti-angiogenic therapies in breast cancer (22-27). Furstenberger et al. (22) reported that CECs were significantly elevated in breast cancer patients and decreased during chemotherapy (anthracycline and/or taxane based). However, EPCs (CD34+/VEGFR-2+) as well as their progenitor cell population CD133+/CD34+ and the population of CD34+ stem cells increased together with VEGF, erythropoietin and angiopoietin-2 levels. Their data suggest that chemotherapy reduces mature CECs, while mobilizing the EPC population. Using real-time PCR and flow cytometry, they also showed that CD146, an endothelial cell specific antigen, was significantly increased in newly diagnosed breast cancer patients compared to healthy controls (23). Other studies also reported increased circulating EPCs in breast cancer patients in addition to CECs (24,25). In another study, circulating EPCs were not increased in cancer patients despite the high plasma VEGF levels (26). Another interesting aspect is that Mancuso et al (27) showed that CEC kinetics correlate with progression-free and overall survival but not circulating progenitor cells in metastatic breast cancer.
- Being tested
- Blood Draw
- Keywords
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawProcedure or surgery
Blood sample will be drawn from a vein in the arm.
| Study group | Role | What they receive |
|---|---|---|
| Case | Women with breast cancer Receives: Procedure: Blood Draw | |
| Control | Women without breast cancer Receives: Procedure: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
To quantitate endothelial progenitor cells (EPCs) in early and advanced breast cancer patients. Different type of EPCs will be isolated from the blood and quantitated.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionMay 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Stage IVStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Responsible party
- Principal investigator, Kathy Miller, Indiana University
- Investigators
- George W Sledge, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00393341
- Sponsor's protocol ID
- 0609-21
- Other IDs
- IUCRO-0168
- Acronym
- EPC
- Status last verified
- Aug 2015
- First submitted
- 25 Oct 2006
- Last updated
- 31 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitation of Endothelial Progenitor Cells as Markers of Tumor Angiogenesis in Breast Cancer
- ClinicalTrials.gov ID
- NCT00393341
- Acronym / sponsor ID
- EPC / 0609-21
- Keywords
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Study start
- Oct 2006
- Primary completion
- May 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 27 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We propose to quantitate endothelial progenitor cells (EPCs) in early and advanced breast cancer patients. Peripheral blood will be drawn from the eligible patients. Different type of EPCs will be isolated from the blood and quantitated.
Detailed description
Accumulating evidence emphasizes the emerging role of circulating endothelial cells (CECs) and endothelial progenitor cells (EPCs) in tumor angiogenesis as surrogate markers and in the efficacy of anti-angiogenic therapies in breast cancer (22-27). Furstenberger et al. (22) reported that CECs were significantly elevated in breast cancer patients and decreased during chemotherapy (anthracycline and/or taxane based). However, EPCs (CD34+/VEGFR-2+) as well as their progenitor cell population CD133+/CD34+ and the population of CD34+ stem cells increased together with VEGF, erythropoietin and angiopoietin-2 levels. Their data suggest that chemotherapy reduces mature CECs, while mobilizing the EPC population. Using real-time PCR and flow cytometry, they also showed that CD146, an endothelial cell specific antigen, was significantly increased in newly diagnosed breast cancer patients compared to healthy controls (23). Other studies also reported increased circulating EPCs in breast cancer patients in addition to CECs (24,25). In another study, circulating EPCs were not increased in cancer patients despite the high plasma VEGF levels (26). Another interesting aspect is that Mancuso et al (27) showed that CEC kinetics correlate with progression-free and overall survival but not circulating progenitor cells in metastatic breast cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Procedure: Blood DrawWomen with breast cancer |
| Control | – | Procedure: Blood DrawWomen without breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women 18 or older with breast cancer recieving treatment at IUSCC and willing to donate a blood sample and complete consent form.
Key inclusion criteria (1 listed)
- Diagnosis of metastatic breast cancer(stage IV), or women with a history of Stage I or II breast cancer disease who are currently disease free Women greater than or equal to 18 years of age Ability to understand and the willingness to sign an informed consent
Key exclusion criteria (1 listed)
- Chemotherapy, radiation, or surgery within the past 4 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood DrawBlood sample will be drawn from a vein in the arm. | Procedure or surgery | Case, Control |
Primary outcome
To quantitate endothelial progenitor cells (EPCs) in early and advanced breast cancer patients. Different type of EPCs will be isolated from the blood and quantitated.
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George W Sledge, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Stage IV and Breast Cancer Stage I, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To quantitate endothelial progenitor cells (EPCs) in early and advanced breast cancer patients. Different type of EPCs will be isolated from the blood and quantitated. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2015.